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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114980
Other study ID # IRB-3000008285
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date January 2027

Study information

Verified date June 2023
Source University of Alabama at Birmingham
Contact Polina Zmijewski, MD
Phone 205-934-3333
Email pzmijewski@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Options for treatment of severe, refractory hypocalcemia are limited for the thousands of patients in the United States who suffer from hypoparathyroidism. Parathyroid allotransplantation is an emerging treatment that provides hope for these individuals. Currently, this therapy has only been successfully provided by a few centers in the world. In the UAB PATH trial, we propose to become one of the few centers worldwide to successfully achieve parathyroid allotransplantation in transplant-naïve patients.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Parathyroid Allotransplant
Patients that meet inclusion criteria and are enrolled in the trial will undergo parathyroid allotransplantation

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parathyroid transplant function Detectable PTH 8 weeks post-operatively
Primary Calcium supplementation Amount and type of calcium supplements needed post-operatively 6 months post-operatively
Secondary Serum calcium level 6 months post-operatively
Secondary Immunosuppression-related adverse events Infections or other adverse events 12 months post-operatively
See also
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Active, not recruiting NCT05328076 - Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
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Completed NCT04059380 - Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1